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According to a new market report published by Transparency Market Research “Regulatory Affairs Outsourcing Market - Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2014 - 2020,” the global regulatory affairs outsourcing market was valued at USD 1.56 billion in 2013 and is expected to grow at a CAGR of 14.6% from 2014 to 2020, to reach an estimated value of USD 4.49 billion in 2020

At present, biopharmaceutical industries are highly synchronized by various regulatory authorities across the globe. For the protection of public health, medical devices and pharmaceutical products are subject to strict regulations. Most of the pharmaceutical companies are opting to outsource their regulatory affairs operations to various competent contract research organizations (CROs) and contract manufacturing organizations (CMOs) in order to acquire timely approval from regulatory bodies. Furthermore, cost efficiencies, process improvement and utilization of the expertise available with the CROs are some of the primary factors which are responsible for the growth of regulatory affairs outsourcing market. Due to higher costs associated with the clinical trial and development procedures and the rising need for cost containment among manufacturing companies and rapid product commercialization, the regulatory affairs outsourcing market is expected to propel during the forecast period of 2014 to 2020.

The regulatory writing and publishing services segment accounted for the largest share, i.e., more than 40% of the total regulatory affairs outsourcing market in 2013. Factors that have contributed towards the growth of the segment are growing need for rapid approval and submission of drug applications. Moreover, regulatory writers have appropriate understanding of the global and domestic regulatory requirements, thereby driving the growth of the regulatory writing and publishing services market. Similarly, in terms of growth rate, the regulatory consulting and legal representation services segment is estimated to grow at the fastest growth rate of over 13% from 2014 to 2020 of the regulatory affairs outsourcing market. Growing pressure for regulatory consulting and increasing need of client interaction with various regulatory agencies has attributed towards the growth of the regulatory consulting and legal representation services segment.

Geographically, North America accounted for the largest share (more than 30%) of the total regulatory affairs outsourcing market in 2013. However, Asia Pacific countries such as Japan, South Korea, Malaysia, Australia, Thailand, India and China are witnessing remarkable growth and are anticipated to grow at a CAGR of over 15% during the forecast period of 2014 to 2020 due to extensive presence of skilled workforce and easy market penetration in developing economies. Favorable support from governments for healthcare infrastructure would further boost the growth of the regulatory affairs outsourcing market in Asia Pacific.